Coiled suture package



1966 P. E. REGAN, JR

COILED SUTURE PACKAGE 2 Sheets-Sheet 1 INVENTOR. fimz f. $564M t/K. BY 4 M MATTORNEY Filed July 16, 1963 Oct. 25, 1966 P. E. REGAN, JR 3;Z80971 GQILED sumw PACKAGE Filed July 16, 1963 2 Sheets-Sheet z I N VEN TOR.

United States Patent "ice 3,280,971 COILED SUTURE PACKAGE Paul E. Regan, Jr., Somerville, N.J., assignor to Ethicon, Inc., a corporation of New Jersey Filed July 16, 1963, Ser. No. 295,447 21 Claims. (Cl. 206-633) The present invention relates to the packaging of elongated sutures and the like, most particularly to the packaging of delicate sutures and packaging several sutures in the same container.

Heretofore, elongated surgical sutures i.e., sutures approximately to inches long, have been packaged singly or in groups in various manners, both with and Without attached needles. Due to their length they normally have been wound in the form of a coil or upon a reel or looped and placed within a sleeve, or wound in some way to reduce the dimension of the package.

When the term suture or sutures is used in this application it shall mean surgical strands used for suturing, ligating and the like, and shall include such strands commonly called either sutures or ligatures.

Many problems have arisen in the packaging of delicate sutures such as thin stainless steel wire sutures and very small gauge sutures. In the case of wire sutures and various other materials, kinks and sharp bends have been formed in the suture during packaging and storage. This may render them unsuitable for delicate work and in some cases, due to the formation of Weak spots and breaks in the suture, they cannot be used at all.

If the suture is very thin or brittle, it is subject to damage during winding and is not properly protected when the package is opened to remove the suture, particularly when several sutures are placed in the same package. Very fine gauge sutures are very difficult to handle and tend to become disarranged and entangled very easily because of their fineness.

When several sutures have been packaged together it has been necessary to remove the Whole group of sutures from the package in order to separate one from the others. In many cases the sutures have been wound or looped around a reel or wound .together in a coil and have become entangled wit-h one another so that the group of sutures mus-t be straightened out before one can be separated. In these cases, it is necessary to rewind or coil the sutures which are not used and secure them together in some way or reinsert them in an envelope, or the like, so that they may be stored and then resterilized before reuse.

According to the present invention, the most delicate sutures may be packaged singly or in combination with several other sutures in such a way that they can be removed easily from the package and will not be kinked or contain any sharp bends or curves. The nature of the package is such that there is no necessity of winding the sutures in the ordinary manner so that the sutures are never exposed to winding stress or the like. Once the sutures are packaged they are fully protected against damage and remain protected until each suture is used. Several sutures may be placed together in the same package and the individual sutures may be removed easily one at a time from the package without disturbing the sutures remaining therein. The sutures may be packaged in groups with or without attached needles and may be removed one at a time from the package, as described above, with equal facility.

According to the present invention, the suture or sutures are packaged in restraining means defining a coiled narrow passageway having a plurality of convolutions which determine the configuration in which the sutures will be coiled. The passageway, which conveniently is defined by a small diameter hollow plastic tube, has a smooth 3,280,971 Patented Oct. 25, 1966 inner surface possessing a high degree of lubricity and the suture restraining means is formed of a material capable of being sterilized by irradiation or by heat without deterioration or detracting from the lubricity of said surface. One or more sutures may be placed inside the passageway with their ends protruding from one end thereof. When the passageway contains a plurality of sutures the sutures are held loosely therein in nonentangling relationship to one another and are adapted to be removed one at a time by drawing them from the passageway by their protruding ends. The individual sutures may be removed easily in this fashion without disturbing the other sutures contained in the passageway. The passageway may be coiled in the form of a spiral, a helix, a figure-eight, or any other smooth curved configuration which will allow a plurality of coils to be formed in a reason-ably small area.

In a preferred embodiment of this invention, the suture restraining means is in the form of small diameter hollow plastic tubing wound in a plurality of convolutions. This is a particularly convenient embodiment since the sutures may be inserted in the tubing while the tubing is still straight and the tubing containing the sutures may be coiled in the desired configuration with no possibility of damaging the sutures.

The material of the tubing or of the suture rest-raining means must be capable of being sterilized by irradiation or by heat, as indicated above. For example, since the only sterilizing facilities available in most hospitals utilize a steam autoclave, this material should be capable of withstanding live steam at a temperature of at least 250 F. without deterioration or loss in lubricity. Polypropylene has been found to be particularly suitable for this use because of its lubricity and its ability to withstand heat without deterioration, as well as its low cost. However, other materials with the required lubricity and the ability to be steam sterilized may be used. Certain types of'high density polyethylene may be suitable and polytetrafluoroethylene would be acceptable if not too costly.

Advantageously, when the suture restraining means is in the form of coiled plastic tubing, the coiled tubing is placed inside a sleeve which holds the tubing in the desired coiled configuration. Preferably in this case, the tubing is flexible and tends to assume a coil of larger diameter than the sleeve so that, when the tubing is inserted in the sleeve, it presses against the side of the sleeve to hold the coil in position. In a preferred form of this package, the sutures protrude from a leading end of the tubing and the leading end of the tubing protrudes from the sleeve. In this case, a two-way flap extends from the same end of the sleeve for covering the leading end of the tubing and the sutures protruding therefrom. This flap is adapted to be folded closed in one direction for insertion into the sleeve for covering the sutures and folded open in the other direction for exposing the sutures. The sleeve includes means for retaining the flap in its folded open position and the flap folds along one line to cover the sutures and along another line in its open position.

Other and further advantages of this invention will be apparent from the following description and claims taken together with the drawings wherein:

FIG. 1 is a view in perspective of a suture package according to a preferred embodiment of this invention wherein a strippable outer envelope is shown;

FIG. 2 is a view partly in section and partly in elevation taken along the line 2-2 of FIG. 1;

FIG. 3 is an enlarged view in perspective of a sleeve of the embodiment of FIG. 1 with the flap open to expose the needles attached to the sutures;

FIG. 4 is an enlarged view in perspective similar to FIG. 3 and showing one of the sutures being drawn from the tube by the needle attached to its end;

FIG. 5 is another enlarged view in perspective of the sleeve and. tube of the preceding figures with the flap folded under the sleeve and tucked under a tab provided for that purpose;

FIG. 6 is a front elevational view of the sleeve of FIG. 5;

FIG. 7 is a bottom plan view of the sleeve of FIG. 5;

FIG. 8 is a greatly enlarged view showing the relationship between one suture and the suture restraining tube;

FIG. 9 is a schematic view showing that the sutures are relatively straight after withdrawal from the tube.

Referring to the drawings, there is shown a package according to a preferred embodiment of this invention wherein a plurality of thin stainless steel wire sutures 11, i.e., three, are held in a narrow passageway 12 defined by a coiled hollow restraining tube 13, which in turn is inserted inside a holding sleeve 14 formed fiom relatively stiff sterilizable sheet material such as virgin paperboard approximately 0.01 inch thick. The exterior of the sleeve 14 preferably is treated so that it is water and blood-stain resistant. A two-way foldable flap 15 is provided at one end of the sleeve, and one end 16 of the restraining tube, hereinafter sometimes referred to as the leading end, is adapted to protrude from the sleeve when the flap 15 is folded in its open position, as shown in FIG. 3. The flap 15 is adapted to be folded closed with an end portion 17 thereof inserted in the sleeve to cover the leading end 16 of the tube and the sutures extending therefrom, as shown in FIG. 1. The sleeve 14, with the restraining tube 13 and sutures contained in the passageway 12 therein, is adapted to be packaged by the manufacturer inside a sealed strippable envelope 18, as shown in FIGS. 1 and 2. The strippable envelope comprises a transparent top sheet 19 and a bottom sheet 20 sealed together along their edges to provide a hermetically sealed sterilizable enclosure for the sleeve 14 and its contents. The sheets 19 and 20 are sealed to one another along a strip 21 which forms a shallow peak 22 at one end of the package and the peak is spaced somewhat from the adjacent ends of the sheets to provide stripping flaps 23 and 24 for opening the package. The flaps 23 and 24 are pulled apart to separate the sheets and break the seal When it is desired to remove the sleeve 14 from the envelope. Printing 25 may be applied to one side of the sleeve to identify its contents and the sleeve is inserted so that it may be read through the transparent side of the envelope 18.

The suture restraining tube 13 is in the form of a coil which is both spiral and helical and comprises about two and one-half convolutions. The tube 13, itself, is a small diameter plastic tube of a material such as polypropylene. The inner surface 26 of the passageway 12 of the tube, itself, is smooth and possesses a high degree of lubricity and the tube is capable of being sterilized by irradiation or by heating to a temperature of at least about 250 F. in the presence of live steam without deterioration or detraction from the lubricity of the inner surface 26. Generally speaking, the inner diameter of the tube 13 is such that, while the tube is narrow enough to provide a definite path for the sutures and means for restraining them in a definite curved configuration, the tube is large enough so that a plurality of sutures contained therein will be held loosely in said passageway 12 in non-entaugling relationship with one another.

In a preferred form of this invention, the restraining tube 13 initially is straight and formed of polypropylene tubing having an outer diameter of about 0.064 inch and an inner diameter of about 0.034 inch. The suture or sutures 11, depending upon whether one or several sutures are to be placed in the same package, are inserted or drawn into the straight tubing until the tubing is fully loaded. If the sutures are relatively stiff they may be inserted directly into the tubing. However, if they are at all filmsy, it is preferred that they be drawn by vacuum into the tubing. Vacuum also is preferred since any suture may be loaded in this manner. After the sutures are loaded, the tubing is coiled in the configuration in which it is desired to coil the suture. The coiling of the tube 13 and sutures 11 is accomplished by contacting the tubing only, without touching any of the sutures. In an alternate technique, the coil may be formed first, or the tubing may be coiled in the desired shape, and the suture or sutures may be drawn by vacuum, or in some cases inserted, into the passageway 12 defined by the coil which is already curved in the configuration in which it is desired to coil the suture.

The sutures 11 are drawn into the tube in such a way that the sutures themselves protrude slightly from the leading end 16 of the coil and individual curved needles 27 are attached to each of the sutures 11 at about the same distance beyond the end 16 of-the tube 13. The sutures 11 may be removed easily one at a time from the tube 13 without disturbing the other sutures contained therein merely by gripping one of the needles 27 and drawing it away from the tube, as shown in FIG. 4.

The tubing is somewhat flexible and, when coiled, tends to assume a coiled configuration of larger diameter than the sleeve 14. Thus, when the coiled tube 13 containing the sutures 11 is inserted in the sleeve 14, it presses against the inside of the sleeve adjacent the top and bottom edges 28 and 29 thereof to hold the coil in position in the sleeve. The coiled tube 13 is placed in the sleeve 14 so that the leading end 16 of the coil, i.e., the one from which the sutures 11 extend, protrudes from the main part of the sleeve, as shown most clearly in FIGS. 3-5. The leading end 16 of the coiled tube 13 is held in position by placing it under a tab 31 which is struck from an end portion 32 of the sleeve. The coiled tube is firmly held by the sleeve and the tab so that a suture may be withdrawn easily from the tube without disturbing the position of the tube in the sleeve. As indicated hereinbefore, a two-way flap 15 is provided at that end of the sleeve to cover the leading end 16 of the coiled tube and the sutures 11 and needles 27 protruding therefrom. The flap 15 folds along a first fold line 33 for folding the flap 15 closed and inserting its end portion 17 in the sleeve and for opening the flap 15 to expose the sutures 11, and along a second fold line 34 which is closer to the tube 13 for restraining the flap 15 in its open position. A series of spaced perforations, or slits, 35 may be included along the second fold line 34 to allow the flap 15 to be folded back sharply under the sleeve 14, as shown in FIGS. 5-7. To hold the flap 15 in its open position, the flap is adapted to be folded along the second fold line 34 and placed under the sleeve, as shown in FIGS. 5-7, with its end portion 17 inserted under a bottom holding tab 36 in the underside of the opposite end of the sleeve. With the flap 15 folded back and the end portion 17 in this position, the sleeve 14 containing the restraining tube 13 and sutures 11 may be placed upon a table 37 without danger of the sutures or needles contacting the surface of the table since they will be supported above the table 37 by the raised front end of the sleeve, as shown most clearly in FIGS. 5 and 6.

It will be seen that the most delicate suture may be packaged according to this invention without danger of damaging the suture during winding or in any subsequent packaging steps and that the suture is fully protected in the restraining coil until it is drawn out for use. Very fine, or gossamer, sutures in the lower gauges may be packaged and retained in the desired coiled configuration without entanglement or damage thereto. It also has been shown that this invention makes possible the packaging of a plurality of sutures inside a single coiled passageway with assurance that the sutures will not become entangled with one another and may be removed easily one at a time without disturbing the other sutures in the passageway merely by drawing them from the passageway by their protruding ends. This is true even if the package has been resterilized by irradiation or in a steam autocla've since the material of the coil retains its lubricity during any such sterilization process.

Having now described the invention in specific detail and exemplified the manner in which it may be carried into practice, it will be readily apparent to those skilled in the art that innumerable variations, applications, modifications, and extensions of the basic principles involved may be made without departing from its spirit or scope.

The invention claimed is:

1. A package for elongated surgical sutures which comprise suture restraining means defining a coiled narrow passageway having a plurality of convolutions, said passageway having a smooth inner surface possessing a high degree of lubricity and said suture restraining means being formed of a material capable of being sterilized by irradiation or by heat without deterioration or detracting from the lubricity of said inner surface; and at least one elongated surgical suture in said passageway.

2. A package for surgical sutures according to claim 1, wherein said passageway is coiled in the form of a spiral.

3. A package for surgical sutures according to claim 1, wherein said passageway is coiled in the form of a helix.

4. A package of surgical sutures according to claim 1, wherein said passageway is coiled in the form of a figure eight.

5. A package for surgical sutures according to claim 1, wherein a plurality of elongated sutures are held loosely in said passageway in non-entangling relationship with one another, and said sutures are adapted to be removed one at a time from one end of said passageway without disturbing the other sutures contained therein.

6. A package for surgical sutures according to claim 1, wherein said suture restraining means is formed from polypropylene.

7. A package for elongated surgical sutures which comprises a small diameter hollow plastic tube in the form of a coil having a plurality of convolutions, said tube presenting a smooth inner surface possessing a high degree of lubricity and being formed of a material capable of being sterilized by irradiation or by heating to a temperature of at least about 250 F. in the presence of live steam without deterioration or detracting from the lubricity of said inner surface, and at least one elongated surgical suture in said tube.

8. A package for surgical sutures according to claim 7, which further comprises a sterile enclosure for said coil.

9. A package for surgical sutures according to claim 7, wherein a plurality of sutures are held loosely in said tube and said sutures protrude from one end of the tube in such a way that they may be gripped one at a time and extracted from the tube without disturbing the position of the other sutures therein.

10. A package for surgical sutures according to claim 9, which further comprises a surgical needle attached to each of the protruding sutures at one end of the tube.

11. A package for surgical sutures according to claim 7, wherein said suture is steel wire.

12. A package for surgical sutures which comprises a length of small diameter hollow plastic tubing wound in a plurality of convolutions, said tubing presenting a high degree of lubricity and being formed of a material capable of being sterilized by irradiation or by steam with out deterioration or detracting from the lubricity of said inner surface, at least one elongated surgical suture in said tube, and a sterile enclosure for the tube and the suture.

13. A package for surgical surtures according to claim 12 wherein said tubing is flexible and said package comprises holding means for maintaining the tubing in its coiled configuration.

14. A package for surgical sutures according to claim 13 wherein said holding means is in the form of a sterilizable sleeve and said tubing tends to assume a coil of larger dimension than said sleeve and is inserted in said sleeve with the tubing pressing against the inside of the sleeve to hold the coil in position.

15. A package for surgical sutures according to claim 14 wherein means is provided adjacent one end of the sleeve for positioning the end of the tubing from which the suture is adapted to be withdrawn.

16. A package for surgical sutures according to claim 14, wherein the sutures protrude from a leading end of the tubing and said leading end protrudes from the sleeve, and which further comprises a two-way flap extending from the same end of the sleeve for covering the leading end of the tubing and sutures protruding therefrom.

17. A package for surgical sutures according to claim 16, wherein said flap folds closed in one direction for insertion into said sleeve for covering said sutures and folds open in the other direction for exposing said sutures, said sleeve comprising means for retaining said flap in its folded open position.

18. A package for elongated surgical sutures which comprises suture restraining means defining a coiled narrow passageway having a plurality of convolutions, said passageway having a smooth inner surf-ace possessing a high degree of lubricity; and a plurality of elongated sutures in said passageway, said sutures being held loosely in said passageway in substantially parallel alignment and in non-entangling relation with one another and being adapted to be removed one at a time from one end of said passageway without disturbing the other sutures contained therein.

19. A package for surgical sutures according to claim 18, wherein said passageway is coiled in the form of a spiral.

20. A package for surgical sutures according to claim 18, wherein said passageway is coiled in the form of a helix.

21. A package for surgical sutures according to claim 18, wherein said passageway is coiled in the form of a figure eight.

References Cited by the Examiner UNITED STATES PATENTS 404,843 6/1889 Johnson 20663.3

433,052 7/1890 Spear 22976 1,446,669 2/ 1923 Sherlock 22976 2,583,043 1/1952 Dean 20663.3 2,617,523 11/1952 Zoller 20663.3 3,037,619 6/1962 Stevans 20663.3 3,062,372 11/1962 Egler et al 20663.3

THERON E. CONDON, Primary Examiner.

I, M. CASKIE, Assistant Examiner, 

1. A PACKAGE FOR ELONGATED SURGICAL SUTURES WHICH COMPRISES SUTURE RESTRAINING MEANS DEFINING A COILED NARROW PASSAGEWAY HAVING A PLURALITY OF CONVOLUTIONS, SAID PASSAGEWAY HAVING A SMOOTH INNER SURFACE POSSESSING A HIGH DEGREE OF LUBRICITY AND SAID SUTURE RESTRAINING MEANS BEING FORMED OF A MATERIAL CAPABLE OF BEING STERILIZED BY IRRADIATION OR BY THE HEAT WITHOUT DETERIORATION OR DETRACTING FROM THE LUBRICITY OF SAID INNER SURFACE; AND AT LEAST ONE ELONGATED SURGICAL SUTURE IN SAID PASSAGEWAY. 